Critical IllnessINVADENCT04265703
The INVADE Study: INnominate Vein Approach for Central Catheterization in Difficult to cannulatE Patients
A study testing Internal jugular vein catheterization, Subclavian vein catheterization and Innominate vein catheterization in people with Critical Illness, run by Hospital Civil de Guadalajara at 1 site in Mexico.
Trial summary
Most recent guidelines suggest central venous access must be performed with real-time ultrasound guidance, and the most recommended site for cannulation is internal jugular vein (IJV); however, it is recognized that evidence for other sites is, at present, limited. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Critical Illness
- What is being tested?
- Internal jugular vein catheterization, Subclavian vein catheterization and Innominate vein catheterization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 315 participants
- Where
- 1 siteMexico
- Study dates
- 27 Feb 2024to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who need central venous catheterization, and have respirophasic variation in cross-sectional area of jugular veins
Who cannot join
- Less than 18 years-old
- Patients with previous failed attempts with non-ultrasound guided technique
- Non-resolved pneumothorax/hemothorax at enrollment
- Refusal to sign informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Guadalupe Aguirre-Avalos, MD contact
Mexico1 site, 1 recruiting
- Recruiting
Hospital Civil Fray Antonio Alcalde
Guadalajara, 44280
Miguel Ibarra-Estrada, MD, 3317593502, drmiguelibarra@hotmail.com
Guadalupe Aguirre-Avalos, MD, guadalupe.aavalos@academicos.udg.mx
About this study
Official title: Central Venous Access in Patients With Difficult Cannulation, A Randomized Controlled Trial
Most recent guidelines suggest central venous access must be performed with real-time ultrasound guidance, and the most recommended site for cannulation is internal jugular vein (IJV); however, it is recognized that evidence for other sites is, at present, limited. Besides, guidelines does not account for patients with small vein cross-sectional area and/or respirophasic collapse, which can make the procedure more difficult or even impossible. The investigators aim to compare three different insertion sites for central venous access, with real-time ultrasound guidance
Read the detailed description
Ultrasound-guided cannulation of central veins is successful in >95% of the cases, according to the largest study so far. However, this and other studies with similar success rate, are performed in patients with general anesthesia and/or neuromuscular blockade, without spontaneous respiratory efforts. Critical care physicians and many other specialists frequently need to cannulate patients in special circumstances as hypovolemia, pain, anxiety, and respiratory efforts that promotes respirophasic variation in cross-sectional area, and even complete collapse of the vessel. These changes can increase the probability of posterior wall or arterial puncture, hematomas, pneumothorax, etc. Supraclavicular approach for cannulation of the subclavian vein is a method described since 1965, also giving direct access to the innominate vein, a larger vessel which is rarely collapsible regardless of volume status or respiratory efforts. Based on a previous pilot trial, in this multi-center, prospective, randomized, controlled trial, the investigators aim to compare the successfulness and safety of ultrasound-guided central venous cannulation at 3 different sites: internal jugular, subclavian, and innominate veins.
- Conditions
- Critical Illness
- Being tested
- Internal jugular vein catheterization, Subclavian vein catheterization, Innominate vein catheterization
- Keywords
- Central venous access, Ultrasound-guided catheterization, Innominate vein, Brachiocephalic vein
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internal jugular vein catheterizationProcedure or surgery
Catheterization of internal jugular vein with real-time (in-plane) method, with neutral neck position. Standard aseptic technique.
Subclavian vein catheterizationProcedure or surgery
Catheterization of subclavian/axillary vein with infra-clavicular approach with real-time (in-plane) method, without shoulder retraction. Standard aseptic technique.
Innominate vein catheterizationProcedure or surgery
Catheterization of innominate vein with supra-clavicular approach with real-time (in-plane) method, with neutral shoulder position and no shoulder retraction. Standard aseptic technique.
| Study group | Role | What they receive |
|---|---|---|
| Internal jugular vein site | Active comparator | Ultrasound-guided central venous catheterization at internal jugular vein site Receives: Procedure: Internal jugular vein catheterization |
| Subclavian vein site | Active comparator | Ultrasound-guided central venous catheterization at subclavian vein site Receives: Procedure: Subclavian vein catheterization |
| Innominate vein site | Active comparator | Ultrasound-guided central venous catheterization at innominate vein site Receives: Procedure: Innominate vein catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cannulation failure rate
Failure to cannulate selected vein at first attempt
Measured: Baseline
Secondary outcomes (8)
Central line-associated blood infection rate
Confirmed with blood cultures
Measured: 28 days
Collapsibility associated with failure
Percentage of vein collapsibility independently associated with cannulation failure
Measured: Baseline
Cannulation number of attempts
Number of attempts needed to attain cannulation
Measured: Baseline
Procedure time
Time from skin puncture to guidewire confirmed into vessel (minutes)
Measured: Baseline
Arterial puncture rate
Confirmed immediately after procedure with vascular ultrasound
Measured: Baseline
Hematoma formation rate
Confirmed immediately after procedure with vascular ultrasound
Measured: 7 days
Neumothorax rate
Confirmed immediately after procedure with lung ultrasound
Measured: 7 days
Hemothorax rate
Confirmed immediately after procedure with lung ultrasound
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start27 Feb 2024
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 315 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Civil de Guadalajara
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Jalisciense de Cancerologia
- Responsible party
- Principal investigator, Miguel Á Ibarra-Estrada, Hospital Civil de Guadalajara
- Investigators
- Miguel Ibarra-Estrada, MD, Principal investigator, Hospital Civil Fray Antonio Alcalde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04265703
- Sponsor's protocol ID
- HCG/CEI-1196/19
- Acronym
- INVADE
- Status last verified
- Mar 2026
- First submitted
- 9 Feb 2020
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Venous Access in Patients With Difficult Cannulation, A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04265703
- Acronym / sponsor ID
- INVADE / HCG/CEI-1196/19
- Conditions
- Critical Illness
- Keywords
- Central venous access, Ultrasound-guided catheterization, Innominate vein, Brachiocephalic vein
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 315 participants (estimated)
- Lead sponsor
- Hospital Civil de GuadalajaraUniversity, hospital or other
- Collaborators
- Instituto Jalisciense de Cancerologia
- Study start
- 27 Feb 2024 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 11 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Most recent guidelines suggest central venous access must be performed with real-time ultrasound guidance, and the most recommended site for cannulation is internal jugular vein (IJV); however, it is recognized that evidence for other sites is, at present, limited. Besides, guidelines does not account for patients with small vein cross-sectional area and/or respirophasic collapse, which can make the procedure more difficult or even impossible. The investigators aim to compare three different insertion sites for central venous access, with real-time ultrasound guidance
Detailed description
Ultrasound-guided cannulation of central veins is successful in >95% of the cases, according to the largest study so far. However, this and other studies with similar success rate, are performed in patients with general anesthesia and/or neuromuscular blockade, without spontaneous respiratory efforts. Critical care physicians and many other specialists frequently need to cannulate patients in special circumstances as hypovolemia, pain, anxiety, and respiratory efforts that promotes respirophasic variation in cross-sectional area, and even complete collapse of the vessel. These changes can increase the probability of posterior wall or arterial puncture, hematomas, pneumothorax, etc. Supraclavicular approach for cannulation of the subclavian vein is a method described since 1965, also giving direct access to the innominate vein, a larger vessel which is rarely collapsible regardless of volume status or respiratory efforts. Based on a previous pilot trial, in this multi-center, prospective, randomized, controlled trial, the investigators aim to compare the successfulness and safety of ultrasound-guided central venous cannulation at 3 different sites: internal jugular, subclavian, and innominate veins.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Internal jugular vein site | Active comparator | Procedure: Internal jugular vein catheterizationUltrasound-guided central venous catheterization at internal jugular vein site |
| Subclavian vein site | Active comparator | Procedure: Subclavian vein catheterizationUltrasound-guided central venous catheterization at subclavian vein site |
| Innominate vein site | Active comparator | Procedure: Innominate vein catheterizationUltrasound-guided central venous catheterization at innominate vein site |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who need central venous catheterization, and have respirophasic variation in cross-sectional area of jugular veins
Key exclusion criteria (4 listed)
- Less than 18 years-old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internal jugular vein catheterizationCatheterization of internal jugular vein with real-time (in-plane) method, with neutral neck position. Standard aseptic technique. | Procedure or surgery | Internal jugular vein site |
| Subclavian vein catheterizationCatheterization of subclavian/axillary vein with infra-clavicular approach with real-time (in-plane) method, without shoulder retraction. Standard aseptic technique. | Procedure or surgery | Subclavian vein site |
| Innominate vein catheterizationCatheterization of innominate vein with supra-clavicular approach with real-time (in-plane) method, with neutral shoulder position and no shoulder retraction. Standard aseptic technique. | Procedure or surgery | Innominate vein site |
Primary outcome
Cannulation failure rate
Time frame: Baseline
Failure to cannulate selected vein at first attempt
8 secondary outcomes
Central line-associated blood infection rate
Time frame: 28 days
Collapsibility associated with failure
Time frame: Baseline
Cannulation number of attempts
Time frame: Baseline
Procedure time
Time frame: Baseline
Arterial puncture rate
Time frame: Baseline
Hematoma formation rate
Time frame: 7 days
Neumothorax rate
Time frame: 7 days
Hemothorax rate
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guadalupe Aguirre-Avalos, MD contact
Miguel Ibarra-Estrada, MD principal investigator
Hospital Civil Fray Antonio Alcalde
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internal jugular vein catheterization, Subclavian vein catheterization and Innominate vein catheterization in people with Critical Illness, run by Hospital Civil de Guadalajara at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Miguel Ibarra-Estrada, MD (3317593502, drmiguelibarra@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cannulation failure rate (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.